The Science Of Substantiation

Editor’s Note: Justin J. Prochnow is an attorney and Shareholder in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal issues affecting the food & beverage, dietary supplement and cosmetic industries.

For those in the beverage, food and supplement industries who were relieved that they would never have to hear about subjects like biology or chemistry again after graduation from high school or college, the recent regulatory climate has brought back some unpleasant memories. Whether being used to determine the safety of ingredients and products or providing substantiation for claims, science has permeated the beverage, food and supplement industries deeper than ever. Science has always been important from the perspective of product development and manufacture; now, it’s become a key to advertising and promotion.

With that broadening of the role of science, companies must now have scientific support for virtually everything they do. Increasingly, they are defending against congressional leaders attacking the safety of the dietary supplement industry or responding to regulatory agencies taking action for unsubstantiated ingredients or claims.

Events of the past few months underscore the growing need for companies, retailers, and distributors to become familiar with the science behind the manufacture and marketing of some of these products.

DIETARY SUPPLEMENT LABELING ACT

In June, U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) introduced a new bill targeting the supplement industry, S-1310 – the Dietary Supplement Labeling Act. While it wasn’t the first bill introduced by Sen. Durbin that targets the supplement industry, 1310 was primarily introduced to target products that allegedly blur the line between dietary supplements and food or beverages. In a press release announcing the bill, Durbin identified specific products such as “Lazy Cakes” and “Drank” as products that are really food and beverages, but are allegedly being marketed as dietary supplements to take advantage of what he perceived as less restrictive regulations, specifically that they do not require the approval from the Food and Drug Administration (FDA) that is needed for use as additives in foods.

Durbin’s statements ignore an important fact. Although ingredients in supplements do not require approval by the FDA as food additives, ingredients still must be dietary ingredients and, as shown by the draft New Dietary Ingredient Notifications guidance issued by the FDA early this summer, if the ingredients are new dietary ingredients, a notification must be filed unless a specific exemption applies.

Furthermore, not all ingredients in conventional food and beverages products must be FDA-approved food additives; an ingredient may also be legally added to conventional foods if it is determined to be GRAS (Generally Recognized As Safe) and companies can make their own GRAS affirmations. When looked at objectively, it is clear that the Dietary Supplement Labeling Act is an attempt to capitalize on the publicity generated over several products that have gained notoriety in order to place further restraints on the supplement industry.

In the press release announcing the bill, Blumenthal added that “truth in labeling and honest marketing is critical to consumer safety – especially in products targeted towards young people – and should be required as an industry standard.” Many people inside the supplement industry do not disagree. However, industry insiders would argue that more laws are not needed; instead, enforcement of the laws and regulations already in place against egregious violators is the answer.

FDA WARNING LETTERS REGARDING SAFETY OF INGREDIENTS

In July, less than a month after Durbin called out Lazy Cakes by name, it seemed like that kind of enforcement was beginning. With the attention generated by the introduction of the Dietary Supplement Labeling Act, it was hardly coincidental that the FDA issued a warning letter to HBB, LLC, the manufacturers of Lazy Cakes – now called Lazy Larry. In the warning letter to HBB, LLC, the FDA cited “various credible sources and reports in the scientific literature” which raise safety concerns about the use of melatonin as a food ingredient. In particular, the FDA cited several studies which indicated the role of melatonin in causing spontaneous malignant tumors and a potential loss of photoreceptor cells in the aging retina. Based on the scientific literature available and the safety concerns raised, the FDA determined that the use of melatonin in a food product does not satisfy the criteria for GRAS status.

If the format and language used in the warning letter to Lazy Larry seemed familiar, that’s because it was very similar to a previous one sent to Innovative Beverage Group in January 2010 regarding “Drank,” as well as the warning letters sent in November 2010 to four companies marketing alcoholic beverages with caffeine. The discussion set forth in the warning letter to Innovative Beverage Group is very pertinent to the HBB, LLC warning letter because it involved concerns over the same ingredient, melatonin. Although “Drank” was a beverage instead of a conventional food, the argument and concerns with safety due to the available scientific literature were the same.

In the warning letters sent to the four companies selling alcoholic beverages with caffeine, the FDA took issue with the use of caffeine in the products. Caffeine has been used in beverages such as soft drinks for many years, but FDA was concerned over the safety of its use in alcoholic beverages. In November 2009, the FDA actually sent out letters to companies requesting evidence that caffeine was GRAS for use in alcoholic beverages. Despite receiving responses from several of the companies, including a GRAS Notice from one of the companies, the FDA still had serious concerns about the safety of caffeinated alcoholic beverage products. Several of the companies did proffer scientific evidence in support of the use of caffeine in alcoholic beverages, but the FDA was unconvinced. To the contrary, the FDA cited publicly available scientific literature about the hazards of combining alcoholic beverages and caffeinated drinks like energy drinks. Similar to the analysis provided for the products containing melatonin, the FDA determined that caffeine for use in an alcoholic beverage was not GRAS or a food additive and therefore, the products were adulterated.

In all three cases, science played a key role in the FDA’s determination of the safety, or lack thereof, for each of the ingredients at issue.

SUBSTANTIATION OF CLAIMS

While science can clearly take on an important factor in determining the safety of an ingredient or product, recognized for such purposes, science has become an even greater factor in the area of claim substantiation. Substantiation is a frequent “buzz word” heard in the industries regulated by the FDA and the Federal Trade Commission (FTC). But despite its frequent use, there is much uncertainty as to what levels of substantiation are actually needed to adequately support claims. This uncertainty exists because the FTC does not have a universal “bright line” test for substantiation, instead reviewing each claim on a case-by-case basis.

The FTC has the primary responsibility for regulating advertising. According to the agency’s “Statement on Deception”, the FTC will find an advertisement deceptive and unlawful if it contains a material representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances. Additionally, each advertiser must have a reasonable basis for all expressed and implied claims before disseminating the advertisement. Essentially, this simplifies down to the basic principles that FTC enforces with respect to advertising; namely, all advertising must be truthful, not misleading and substantiated.

REASONABLE BASIS

There are several factors that the FTC considers when determining whether an advertiser has a reasonable basis for making a claim. The type of product and the type of claim weigh heavily in such a determination. Claims promoting products that affect consumer health or safety will, as a general rule, require higher levels of substantiation than other products. Additionally, advertising or labeling that promotes effects that are not easily assessed or verified will also command higher levels of scientific support. For example, a claim that something “tastes great” is likely to warrant a low level of support, both because it is highly subjective and because a consumer can make the determination for himself or herself. However, a claim that a product has a certain physiological effect or provides benefits at a microscopic level is difficult for a consumer to verify on his or her own; therefore, the FTC is likely to require a higher level of substantiation to ensure that consumers are not being misled.

Beyond scientific accuracy, other factors include the possible repercussions from a false claim. If a false claim could cause injury to a consumer, like foregoing a proven treatment, the FTC is likely to require a heightened level of support. Also – and this is a key issue when dealing with bureaucracy – those kinds of claims are also likely to move to the top of the FTC’s regulatory agenda. The FTC also looks at the amount of substantiation that experts in a particular field believe is reasonable to assist the determination as to whether there is a reasonable basis for a particular claim. When there is an existing standard for substantiation developed by a government agency or other authoritative body, the FTC usually accords great deference to that standard. For claims relating to the health or safety of a product, including health claims for food and beverage products, that standard is “competent and reliable scientific evidence.”

COMPETENT AND RELIABLE SCIENTIFIC EVIDENCE

Still, that’s where things get hairy, because there is no statute or regulation that defines “competent and reliable scientific evidence.”

To date, the FTC has self-defined that standard in FTC orders as “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Recitation of that definition, sadly, often leads to the scratching of heads and blank stares and the resulting question “What does that mean?” Unfortunately, there is no definitive answer. What constitutes “competent and reliable scientific evidence” in the eyes of the FTC seems to change on a case-by-case basis. This makes it challenging for companies to ensure that they have properly substantiated their advertising and labeling claims.

They have tried to help. In a guidance document titled “Dietary Supplements: An Advertising Guide for Industry,” the FTC identifies several factors that may help determine the level of substantiation necessary for a particular claim. First of all, the claim itself may help establish the level of scientific support needed. If an advertising claim asserts a certain level of support, an advertiser must have at least the level of support that is claimed, expressly or by implication, to exist. For example, if an advertiser uses the statement “clinically proven,” the advertiser must have clinical studies that support its claim.

If no specific level of support is claimed, the amount of substantiation needed depends, again, on the nature of the claim. A guiding principle for determining the amount and type of evidence that will be sufficient is to consider what experts in the relevant area of study would generally consider to be adequate. The FTC will evaluate all forms of scientific evidence to determine whether the substantiation level is met. Generally, well-controlled human clinical studies are considered to be the most reliable. (The FTC, as a general rule, values the quality of a study over the quantity of scientific evidence produced.) A study that is carefully controlled, with blinding of subjects and researchers, is likely to yield more reliable results. A study of longer duration can provide better evidence that the claimed effect will persist and resolve potential safety questions.

But even when reliable studies are in place, one of the most common problems in claim substantiation is that the study reports relied upon do not support the claim that is being made. Marketers, often anxious to promote a product, exaggerate the benefits of a product as disclosed by the study report or ignore limiting features of a study, like a limited number of participants or a short time frame. The amount of a particular ingredient in a product should correspond to the amount used in the study substantiating the claim or the study may not support the claims made about the product. For example, a study touting the benefits of Vitamin C at 1000 mg probably will not support claims made for a product with 20 mg. Supporting scientific evidence and study reports must be verified to ensure that they properly substantiate marketer claims.

READY AND WAITING WITH SCIENCE IN HAND

Companies cannot simply rely on the scientific substantiation referenced by others and mentioned in reports on-line. Companies should keep their own substantiation files for each of the material claims made about their products. Conducting a clinical trial is often the best and most persuasive evidence in support of claims. There are also some excellent companies that cater to the food, beverage and supplement industries and maintain large repositories of scientific information that could support claims for particular ingredients. At the end of the day, every company in the food, beverage and supplement industries must be prepared to produce scientific support to substantiate claims, ingredients and the safety of products.